An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery

NCT01783483 | Completed Results

• 2 other identifiers: 0712SLBlu
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 12

Brief Summary

The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.

Conditions

Coronary Artery Disease; Angina Pectoris; Cardiac Valve Disease

Keywords

CABG; Valve replacement; sternal closure; midline sternotomy; sternal plates

Outcome Measures

Primary Outcomes (2)

• Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing

  Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular 2. \- Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins 3. \- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension 4. \- Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome

  3-month post-op

• Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing

  Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular 2. \- Early healing: Faint mineralization between non-contacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins 3. \- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension 4. \- Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome

  6-month post-op

Secondary Outcomes (10)

• Pain Measured in a 10-point Scale at Day 7 Post Operative

  Day 7

• Pain Measured in a 10-point Scale at 3-week Post Operative

  3-week Post-op

• Pain Measured in a 10-point Scale at 6-week Post Operative

  6-week Post-op

• Pain Measured in a 10-point Scale at 3-month Post Operative

  3-month Post-op

• Pain Measured in a 10-point Scale at 6-month Post Operative

  6-month Post-op

Study Arms (2)

Suture Wire

ACTIVE COMPARATOR

The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).

Device: Suture Wire

SternaLock Blu closure system

EXPERIMENTAL

Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.

Device: SternaLock Blue closure system

Interventions

SternaLock Blue closure system DEVICE

SternaLock Blue closure system is a primary closure system plate-based

Also known as: SternaLock, SternalBlu

SternaLock Blu closure system

Suture Wire DEVICE

Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.

Suture Wire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a full standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
• Patients admitted to the hospital the day of or the day before their scheduled surgical procedure
• Patients ≥ 18 years of age
• Patients with a BMI \< 40

You may not qualify if:

• Pre-operative
• Patients with endstage renal failure who are on dialysis
• Patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 \< 50% or patients on on-home oxygen)
• Patients on prescribed pre-operative narcotics
• Patients taking chronic steroids, biologics acting as immunosuppressants (e.g. Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), or chemotherapeutics (iv or oral chemotherapeutics for cancer). Patients using a steroid inhaler for asthma should not be excluded.
• Patients with an active infection as defined by a positive culture
• Patients with foreign body sensitivity
• Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
• Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
• Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
• Patients unwilling or unable to return for follow-up
• Operative
• Patients requiring delayed sternotomy closure
• Patients with an off-midline sternotomy reducing the bony margin between a SternaLock screw body and an osteotomy to within 2mm or less
• Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude the use of either wire cerclage or rigid fixation, or who are not able to be plated or wired per the protocol (e.g. patients who in the opinion of the surgeon have insufficient quantity of quality of sternal bone; redo sternotomy with excessive fibrous tissue)

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (12)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

United Heart & Vascular Clinic, United Hospital, part of Allina Health

Saint Paul, Minnesota, 55102, United States

Location

Saint Luke's Mid America Heart and Vascular Institute

Kansas City, Missouri, 64111, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Lenox Hill Hospital

New York, New York, 10065, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Related Publications (15)

• Bennett-Guerrero E, Phillips-Bute B, Waweru PM, Gaca JG, Spann JC, Milano CA. Pilot study of sternal plating for primary closure of the sternum in cardiac surgical patients. Innovations (Phila). 2011 Nov;6(6):382-8. doi: 10.1097/IMI.0b013e318248fbda.

  PMID: 22436774 BACKGROUND

• Casha AR, Yang L, Kay PH, Saleh M, Cooper GJ. A biomechanical study of median sternotomy closure techniques. Eur J Cardiothorac Surg. 1999 Mar;15(3):365-9. doi: 10.1016/s1010-7940(99)00014-7.

  PMID: 10333037 BACKGROUND

• Chou SS, Sena MJ, Wong MS. Use of SternaLock plating system in acute treatment of unstable traumatic sternal fractures. Ann Thorac Surg. 2011 Feb;91(2):597-9. doi: 10.1016/j.athoracsur.2010.07.083.

  PMID: 21256325 BACKGROUND

• Raman J, Lehmann S, Zehr K, De Guzman BJ, Aklog L, Garrett HE, MacMahon H, Hatcher BM, Wong MS. Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial. Ann Thorac Surg. 2012 Dec;94(6):1854-61. doi: 10.1016/j.athoracsur.2012.07.085. Epub 2012 Oct 25.

  PMID: 23103010 BACKGROUND

• Hirose H, Yamane K, Youdelman BA, Bogar L, Diehl JT. Rigid sternal fixation improves postoperative recovery. Open Cardiovasc Med J. 2011;5:148-52. doi: 10.2174/1874192401105010148. Epub 2011 Jul 4.

  PMID: 21760857 BACKGROUND

• Neaman KC, Blount AL, Kim JA, Renucci JD, Hooker RL. Prophylactic sternal plating with pectoralis advancement flaps after sternotomy in patients with a history of chest irradiation. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):355-8. doi: 10.1510/icvts.2010.247262. Epub 2010 Dec 7.

  PMID: 21138917 BACKGROUND

• Snyder CW, Graham LA, Byers RE, Holman WL. Primary sternal plating to prevent sternal wound complications after cardiac surgery: early experience and patterns of failure. Interact Cardiovasc Thorac Surg. 2009 Nov;9(5):763-6. doi: 10.1510/icvts.2009.214023. Epub 2009 Aug 26.

  PMID: 19710069 BACKGROUND

• Lee JC, Raman J, Song DH. Primary sternal closure with titanium plate fixation: plastic surgery effecting a paradigm shift. Plast Reconstr Surg. 2010 Jun;125(6):1720-1724. doi: 10.1097/PRS.0b013e3181d51292.

  PMID: 20517097 BACKGROUND

• Shifrin DA, Sohn SM, Stouffer CW, Hooker RL, Renucci JD. Sternal salvage with rigid fixation in the setting of a massive mediastinal aortic pseudoaneurysm: a case report and review of the literature. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):e17-20. doi: 10.1016/j.bjps.2007.09.022. Epub 2007 Nov 26.

  PMID: 18033747 BACKGROUND

• Raman J, Straus D, Song DH. Rigid plate fixation of the sternum. Ann Thorac Surg. 2007 Sep;84(3):1056-8. doi: 10.1016/j.athoracsur.2006.11.045.

  PMID: 17720442 BACKGROUND

• Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.

  PMID: 17670585 BACKGROUND

• Dickie SR, Dorafshar AH, Song DH. Definitive closure of the infected median sternotomy wound: a treatment algorithm utilizing vacuum-assisted closure followed by rigid plate fixation. Ann Plast Surg. 2006 Jun;56(6):680-5. doi: 10.1097/01.sap.0000202825.41069.c3.

  PMID: 16721085 BACKGROUND

• Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.

  PMID: 15296898 BACKGROUND

• Song DH, Agarwal JP, Jeevanandam V. Rigid sternal fixation in the cardiac transplant population. J Thorac Cardiovasc Surg. 2003 Sep;126(3):896-7. doi: 10.1016/s0022-5223(03)00605-6. No abstract available.

  PMID: 14502187 BACKGROUND

• Pai S, Gunja NJ, Dupak EL, McMahon NL, Roth TP, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg. 2005 Sep;80(3):962-8. doi: 10.1016/j.athoracsur.2005.03.089.

  PMID: 16122464 BACKGROUND

Related Links

• SternaLock Blu Primary Closure System Brochure
• SternaLock Blu Product Description

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

At closing of this study, only 2 prospective RCTs have been conducted that compare RPF with WC. Because both were done with first and second generation devices from the same manufacturer, conclusions on the class effect of RPF systems cannot be made.

Results Point of Contact

• Title: Brian M Hatcher, PhD
• Organization: Zimmer Biomet

brian.hatcher@zimmerbiomet.com

904-741-4400

Study Officials

• Keith B Allen, M.D.

  St Luke's Mid America and Vascular Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 8, 2017
• Results First Posted: September 8, 2017

Record last verified: 2017-08

Locations

US (12)